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Parallel import of medicinal products - When is repackaging necessary?

The parallel import of medicinal products has always been a heavily debated topic, not least because it is a real challenge to reconcile the interests of both the trademark owner and the parallel importer while safeguarding public health. Not surprisingly the Court of Justice of the European Union (“CJEU”) has been asked on several occasions to provide guidance and clarify the principles in this matter.

One of the most debated issues has been – and still is – to determine when the parallel importer is allowed to repackage the medicinal products. It was in the landmark Bristol-Myers Squibb and others-case (joined Cases C-427/93, C-429/93 and C-436/93) that on the 16 July 1996 the CJEU ruled that the trademark owner has the right to oppose the repackaging of the medicinal products by the parallel importer, unless, amongst other conditions, the repackaging is necessary to enable the product to be marketed in the relevant member state (“BMS-decision”).

In Belgium, the “necessity” to repackage medicinal products was addressed again in a case in which Merck Sharp & Dohme Corp (“MSD”) opposed Belgian parallel importer Impexeco SA (“Impexeco”). MSD is the owner of the Benelux trademark ‘Cozaar’ and markets in Belgium, under this trademark and through its affiliate MSD Belgium SPRL, a medicinal product with the active ingredient Losartan. Losartan is effective for the treatment of high blood pressure (hypertension) and lowers the risk of stroke in certain people with heart disease. MSD obtained marketing authorisation in Belgium for Losartan 50mg in a packaging of 28, 56 and 96 tablets. Impexeco obtained authorisation to import Cozaar 50 mg in packets of, among others, 28, 56 and 96 tablets from Poland to Belgium. Impexeco proceeded to import the 28 tablet packets and subsequently repackaged them in a new packaging of 96 tablets. However, in Poland MSD also sold the Cozaar 50mg medicinal products in a 56 and 96 tablet packaging.

MSD opposed Impexeco’s activities stating that the repackaging was only driven by economic reasons. According to MSD, Impexeco could have marketed the original 28 tablet packaging through bundling (in 3 packages of 28 tablets and adding 1 blister of 14 tablets in one of the 3 packages) and subsequently overstickering the bundled packages.

By judgment of 8 February 2013, the Commercial Court of Mons granted MSD’s claim and prohibited Impexeco from commercialising any Cozaar medicinal products in Belgium. Impexeco appealed this decision. In its judgment of 14 September 2015, the Court of Appeal of Mons set aside the decision of 8 February 2013 of the Commercial Court of Mons and ruled that it had been established that there was an objective need to repackage the Polish Cozaar medicinal products. It based its decision on the following grounds:

Cozaar is a medicinal product used for long term treatment, which implies it is prescribed by doctors in large size packaging (i.e. the 96 tablets packaging);

Cozaar 50 mg in packets of 96 tablets represents the most important market share in Belgium of all Cozaar medicinal products;

Impexeco must have access to each part of the market and restricting such access, certainly when it concerns the most important part of the market, is not acceptable;

the mere existence of different packaging sizes is as such not sufficient to conclude repackaging is not necessary;

bundling and overstickering would not be an option in this case because:-

according to the BMS-decision, bundling implies the mere combination of existing packages, while in this case there would not only be bundling of 3 existing packages of 28 tablets, but also adding 1 blister of 14 tablets to one of those 3 packages, which could cause confusion and errors in the package leaflet;

the market survey conducted by Impexeco with pharmacists in order to enquire about consumers’ perception on the Cozaar bundled and overstickered packaging should be considered as a serious presumption of the existence of a real impediment to marketing the products in such bundled and overstickered packaging; and

the market survey conducted by MSD could not be considered convincing enough to conclude to the contrary, as the methodology and the way the questions were presented/formulated were completely different and at certain points biased.

Of course, this decision deals with a very specific situation of repackaging and it remains to be seen whether it will still stand once the CJEU has given judgement in the Ferring Laegemidler-case (C-297/15) referred to the CJEU by the Danish Sø- og Handelsretten on 18 June 2015 (“Ferring case”). The preliminary ruling in the Ferring case concerns the possibility of a trademark owner objecting to the marketing of a medicinal product by a parallel importer, where the importer has repackaged the medicinal product in new packaging and reaffixed the trade mark in the two following situations:

the trademark owner has marketed the medicinal product in the same volume and package sizes in all EEA countries where the medicinal product is sold; and

the trademark owner has, in both the country of export and the country of import, marketed the medicinal product in two different package sizes (a small and a larger size) and the importer has purchased medicinal products in one of package sizes (e.g. the larger size) in the country of export and repackaged them in the other package size (e.g. smaller size), on which the trademark has been reaffixed before the products are marketed in the country of import.

Compare jurisdictions:Life Sciences: Product Regulation and Liability

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